Merit Medical Systems, Inc. 2025-04-30 Health serious FDA
Health · FDA · Recall #FDA-Z-1640-2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly Recall
Issued April 30, 2025 · Merit Medical Systems, Inc.
In April 2025, Merit Medical Systems, Inc. recalled the Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
What you should do
- 1 Stop using Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Merit Medical Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Merit Medical Systems, Inc.
- Category
- Health
- Recall date
- April 30, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, M
- Recall number
- FDA-Z-1640-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Merit Medical Systems, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.